CHICAGO, IL, Jun 09, 2007 (MARKET WIRE via COMTEX News Network)
-- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo
Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), has presented results
from a Phase III randomized, double-blind, placebo-controlled
clinical trial evaluating Frova (frovatriptan succinate) 2.5 mg
tablets as a six-day preventative treatment in women with
difficult-to-treat menstrual migraine (MM). The data demonstrated
that FROVA significantly reduced the frequency and severity of MM
as well as the disabilities related to them. The results, which
were presented here today at the annual meeting of the American
Headache Society (AHS), were from the second of the two successful
Phase III placebo-controlled clinical trials evaluating the
efficacy and safety of FROVA in MM prophylaxis.
Women receiving FROVA started the six-day regimen two days prior to
the onset of their anticipated headache. Starting treatment two
days before the expected headache ensures that patients have
adequate blood levels at the time they usually start to experience
MM, and continuing treatment for six days ensures that they are
covered during the whole period when they are likely to experience
those headaches. Women in the study had responded poorly to
previous acute triptan treatment for MM.

"In this study, appropriately timed short-term treatment with
FROVA prevented or significantly reduced the pain of
difficult-to-treat but often predictable migraines associated with
the menstrual period," said the lead investigator in the trial, Jan
Lewis Brandes, M.D., of the Nashville Neuroscience Group and
assistant clinical professor of the Department of Neurology at
Vanderbilt University School of Medicine. "This is exciting news
for women and their physicians who need to realize that the
debilitating pain of menstrual migraine is not inevitable and is
not a normal part of their menstrual cycle."

"In pati
ents with menstrual migraine and predictable menses, I
am intrigued by the potential for a short-term prevention treatment
to prevent or minimize MM symptoms without continuously exposing
patients to a drug," said Stephen Silberstein, M.D., professor of
neurology at the Jefferson Medical College of Thomas Jefferson
University, director of the Jefferson Headache Center and lead
investigator of the initial efficacy study of FROVA for the
short-term prevention of menstrual migraine.

Study Results

In the trial, the MM status of study participants was confirmed
during a placebo-controlled, single-blind, run-in phase. Women were
randomized in the double-blind study to receive FROVA 2.5 mg once a
day, FROVA 2.5 mg twice a day, or placebo (ratio 3:2:3).

FROVA once or twice daily significantly improved the number of
headache-free perimenstrual periods (PMPs) compared to women who
received placebo. FROVA also significantly reduced the incidence of
severe migraines and therefore tended to improve the ratio of
severe to mild headache compared to women who received placebo.
Efficacy data were collected from 410 women in North America and
Europe, 85 percent of whom participated in the study over three
PMPs. Efficacy data were collected from 410 women in North America
and Europe, 85 percent of whom participated in the study over three
PMPs.

The study's primary endpoint was the number of completely
headache-free PMPs. FROVA therapy significantly improved the number
of headache-free PMPs per patient (0.92 [twice daily], p <
0.0001; 0.69 [once daily], p=0.009) versus 0.42 (placebo). The
incidence of severe headache was significantly less with FROVA once
daily (44 percent; p=0.007) and twice daily (40 percent; p=0.0003)
compared with placebo (58 percent), lowering the ratio of severe to
mild migraine from 11:1 with placebo to 4:1 [once daily] and 2:1
[twice daily] with FROVA.

Both FROVA regimens were equally well tolerated with a low rate
of adverse events. The most commonly reported adverse events were
upper respiratory tract infection (37 patients), nausea (36
patients), and dizziness (31 patients). Most adverse events were
rated mild or moderate in severity and did not increase in severity
with increasing doses of FROVA; the percentage rated severe was 19
percent in the placebo group and 22 percent (once daily) and 14
percent (twice daily) in the FROVA groups.

Endo has submitted a supplemental New Drug Application (sNDA)
for FROVA 2.5 mg tablets for the short-term (six days per month)
prevention of MM to the U.S. Food and Drug Administration
(FDA).

About Menstrual Migraine

Menstrual migraine, distinct from other types of migraines, is
largely an under-recognized condition. Of the approximately 21
million women in the U.S. who experience migraines, up to 60
percent suffer from MM and its debilitating effects. More than half
of these women, however, may not be correctly diagnosed, and
therefore may not be receiving adequate treatment. MM has been
reported to be more severe and last longer than other migraines,
and women who suffer from MM may experience significant
restrictions in their daily activities. For many women with MM,
currently available treatment options may not adequately reduce the
debilitating symptoms, such as pain, nausea and vomiting, nor the
migraine's duration. For more information about MM, visit
www.menstrualmigraine.org.

Important Information about FROVA

FROVA is indicated for the acute treatment of migraine attacks
with or without aura in adults. FROVA is not intended for the
prophylactic therapy of migraine o
r for use in the management of
hemiplegic or basilar migraine. The safety and effectiveness of
FROVA have not been established for cluster headache, which is
present in an older, predominantly male population.

FROVA should only be used when a clear diagnosis of migraine has
been established.

As with other drugs in this class, FROVA should not be given to
patients with ischemic heart disease (e.g., angina pectoris,
history of myocardial infarction, or documented silent ischemia),
or to patients who have symptoms or findings consistent with
ischemic heart disease, coronary artery vasospasm, including
Prinzmetal's variant angina or other significant underlying
cardiovascular disease.

FROVA should not be given to patients with cerebrovascular
syndromes including (but not limited to) strokes of any type, as
well as transient ischemic attacks.

FROVA should not be given to patients with peripheral vascular
disease including (but not limited to) ischemic bowel disease.

FROVA should not be given to patients with uncontrolled
hypertension.

It is strongly recommended that FROVA not be given to patients
in whom unrecognized coronary artery disease (CAD) is predicted by
the presence of risk factors unless a cardiovascular evaluation
provides satisfactory clinical evidence that the patient is
reasonably free of coronary artery and ischemic myocardial disease
or other significant underlying cardiovascular disease.

It is strongly recommended that patients who are intermittent
long-term users of 5-HT1 agonists, including FROVA, and who have or
acquire risk factors predictive of CAD, undergo periodic
cardiovascular evaluation as they continue to use FROVA.

The development of a potentially life-threatening serotonin
syndrome may occur with triptans, including FROVA treatment,
particularly during combined use with selective serotonin reuptake
inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors
(SNRIs). If concomitan
t treatment with FROVA and an SSRI (e.g.,
fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram,
escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically
warranted, careful observation of the patient is advised,
particularly during treatment initiation and dose increases.

The most common side effects associated with the use of FROVA
are dizziness, fatigue, paresthesia, flushing, headache, dry mouth,
hot or cold sensation, skeletal pain, chest pain, and
dyspepsia.

About Endo

A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc.,
Endo Pharmaceuticals is a fully integrated specialty pharmaceutical
company with market leadership in pain management products. The
company researches, develops, produces and markets a broad product
offering of branded and generic pharmaceuticals, meeting the needs
of healthcare professionals and consumers alike. More information,
including this and past press releases of Endo Pharmaceuticals
Holdings Inc. is available online at www.endo.com.

Forward-Looking Statements This press release contains
forward-looking statements, within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, as amended, that are based on management's
beliefs and assumptions, current expectations, estimates and
projections. Statements that are not historical facts, including
statements which are preceded by, followed by, or that include, the
words "believes," "anticipates," "plans," "expects" or similar
expressions and statements are forward-looking statements. Endo's
estimated or anticipated future results, product performance or
other non-historical facts are forward-looking and reflect Endo's
current perspective on existing trends and information. Many of the
factors that will determine the Company's future results are beyond
the ability of the Company to control or predict. These statements
are subjec
t to risks and uncertainties and, therefore, actual
results may differ materially from those expressed or implied by
these forward-looking statements. The reader

should not rely on any forward-looking statement. The Company
undertakes no obligation to update any forward-looking statements
whether as a result of new information, future events or otherwise.
Several important factors, in addition to the specific factors
discussed in connection with these forward-looking statements
individually, could affect the future results of Endo and could
cause those results to differ materially from those expressed in
the forward-looking statements contained in this press release.
Important factors that may affect future results include, but are
not limited to: market acceptance of the Company's products and the
impact of competitive products and pricing; dependence on sole
source suppliers; the success of the Company's product development
activities and the timeliness with which regulatory authorizations
and product launches may be achieved; successful compliance with
extensive, costly, complex and evolving governmental regulations
and restrictions; the availability on commercially reasonable terms
of raw materials and other third party manufactured products;
exposure to product liability and other lawsuits and contingencies;
dependence on third party suppliers, distributors and collaboration
partners; the ability to timely and cost effectively integrate
acquisitions; uncertainty associated with pre-clinical studies and
clinical trials and regulatory approval; uncertainty of market
acceptance of new products; the difficulty of predicting FDA
approvals; risks with respect to technology and product
development; the effect of competing products and prices;
uncertainties regarding intellectual property protection;
uncertainties as to the outcome of litigation; changes in operating
results; impact of competitive products and pricing; product
development; changes in laws and re
gulations; customer demand;
possible future litigation; availability of future financing and
reimbursement policies of government and private health insurers
and others; and other risks and uncertainties detailed in Endo's
filings with the Securities and Exchange Commission, including its
Registration Statement on Form 10-K filed with the SEC on March 1,
2007. Readers should evaluate any statement in light of these
important factors.

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